[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646336":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":18,"centralContacts":27,"locations":36,"responsibleParty":54,"collaborators":18,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":66,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":18,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":18,"overallStatus":80,"whyStopped":18,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"University Children's Hospital, Zurich","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Congenital Heart Disease Children Intervention Group","EXPERIMENTAL","The children in the intervention group will participate in the 12-week long E-Fit intervention to enhance their executive functions.",[13],"Other: E-Fit Intervention",{"label":15,"type":16,"description":17,"interventionNames":18},"Congenital Heart Disease Children Control Group","NO_INTERVENTION","Children in this group will fill in daily activity logs during the 12 week period. After data collection they will get access to a delayed E-Fit Intervention.",null,{"label":20,"type":16,"description":21,"interventionNames":18},"Healthy Control Group","Children in this group will fill in daily activity logs during the 12 week period.",[23],{"type":6,"name":24,"description":25,"armGroupLabels":26,"otherNames":18},"E-Fit Intervention","The E-Fit Intervention lasts a total of 12 weeks and consists of three parts: strategy coaching, computerized training, and a analog games.\n\nFor the strategy coaching, the children meet once a week with a member of the study team. During these sessions, they discuss challenges from their everyday lives and work together to find solutions and develop helpful strategies.\n\nIn the computerized training, the children train three times per week for 20 minutes each time. The games are designed to improve executive functions including working memory, cognitive flexibility, planning and inhibition.\n\nIn addition, families receive card or board games. They can decide for themselves whether and how often they play these games at home.\n\nThere are also three coaching sessions with parents, addressing the discussed strategies, as well as challenges faced by children with cCHD. Optionally, teachers will receive an eLearning course.",[9],[28,33],{"name":29,"role":30,"phone":31,"phoneExt":18,"email":32},"Prof. Dr. med. Bea Latal","CONTACT","+41 44 249 63 95","bea.latal@kispi.uzh.ch",{"name":34,"role":30,"phone":18,"phoneExt":18,"email":35},"Prof. Dr. Ruth O'Gorman Tuura","ruth.tuura@kispi.uzh.ch",[37],{"facility":38,"status":18,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"University Children's Hosptial Zurich","Zurich","Canton of Zurich","8008","Switzerland","CH",{"type":45,"coordinates":46},"Point",[47,48],8.55,47.36667,{"lat":48,"lon":47},[51,53],{"name":52,"role":30,"phone":31,"phoneExt":18,"email":32},"Prof. Dr. med Bea Latal",{"name":34,"role":30,"phone":18,"phoneExt":18,"email":35},{"type":55,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"SPONSOR_INVESTIGATOR","Bea Latal","Prof. Dr. med Beatrix Latal","100646336","executive-function-intervention-for-children-with-complex-congenital-heart-disease-100646336",false,"NCT07692958","Executive Function Intervention for Children With Complex Congenital Heart Disease","Executive Function Intervention for Children With Complex Congenital Heart Disease: A Randomised Control Study","E-Fit Heart","Inclusion Criteria:\n\n* Children with CHD: Born with CHD; Underwent cardiopulmonary bypass surgery before the age of one; Children with a genetic disorder or syndromal disorder will be included, if standardized IQ testing with WISC-V can be conducted, and self-rated questionnaires can be filled in; Aged 9 years 0 months to 13 years 11 months (at time of recruitment); Oral informed consent by potential participants (all ages) and parents, as well as written informed consent of parents; EF deficits showing in screening (BRIEF-score ≥ 60)\n* Healthy Controls: Aged 9 years 0 months to 13 years 11 months (at time of recruitment); Oral informed consent by potential participants (all ages) and parents, as well as written informed consent of parents\n\nExclusion Criteria:\n\n* Children with CHD: Heart surgery without cardiopulmonary bypass; Children with known large cerebral lesions or injuries, including stroke and severe hypoxic-ischemic encephalopathy with significant neurological sequelae; Insufficient German language skills of the child and parent(s); Attending a separative special educational school (Separative Sonderschulung)\n* Healthy Controls: preterm birth (\\\u003C36 weeks of gestation); diagnosed with a neurological or substantial developmental disorder (e.g., learning disorder, attention deficit hyperactivity disorder or autism spectrum disorder); Insufficient German language skills of the child and parent(s); Attending a separative special educational school (Separative Sonderschulung)",true,"ALL","9 Years","13 Years",{"count":71,"type":72},160,"ESTIMATED","INTERVENTIONAL",[75],"NA","Children with complex congenital heart disease (cCHD) nowadays survive thanks to medical advances into their teenage years and adulthood. However, many of them have difficulties with so-called executive functions. These include skills such as paying attention, planning, self-control, and flexible thinking, which are very important for school, daily life, and becoming independent. These difficulties are linked to changes in the brain and to a higher level of stress. Previous computer-based training programs on their own have either not been very effective, or the effects were lost soon after.\n\nIn this study, the researchers are testing a newly developed, personalized training program called E-Fit. It combines digital cognitive training, individualized online strategy coaching and analog games. The goal is to find out whether this program can improve executive functions in everyday life for 9-to 13-year-old children with complex congenital heart disease.\n\nThe study is planed as a randomized controlled trial at the University Children's Hospital Zurich. Children will be assigned either to the training group or to a control group. In addition, the results will be compared with those of a group of healthy children of the same age. The children will visit the University Children's Hospital Zurich three times throughout the whole duration of the study. The first visit will take place before the children start the intervention, the second visit right after the children finished the intervention and the last visit will be 3 months after finishing the intervention. During all these visits neuropsychological assessments, questionnaires, brains scans (MRI) and stress measurements will be collected.\n\nThe results are intended to help develop effective support programs for these children, improve their well-being, and better prepare them for transition into adulthood.",[78,79],"Heart Defect, Congenital","Executive Dysfunction","NOT_YET_RECRUITING","2026-07-02",{"date":83,"type":84},"2026-07-09","ACTUAL",{"date":86,"type":72},"2026-08",{"date":88,"type":72},"2030-12",{"name":56,"class":6},1]